Catheter

ABSTRACT

A catheter is configured to prevent kinking of a catheter during handling or mounting of a pressure device. The catheter has a proximal end of its catheter shaft that is provided with a bending section having a flexibility greater than that of the section of the catheter shaft joining the proximal end.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. application Ser. No. 10/725,374,filed Dec. 3, 2003, now U.S. Pat. No. 8,105,311, which claims priorityto European Patent Application No. 02027767.9, filed Dec. 11, 2002, thecontents of each of the foregoing applications are incorporated herein,in their entirety, by this reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention generally relates to a catheter that is not prone tokinking.

2. Background Information

A generic catheter is disclosed in U.S. Pat. No. 5,569,200, whichbasically comprises a catheter shaft that is normally designated as a“hypotube”. A fitting, preferably in the form of a luer fitting, isprovided at the proximal end of said catheter shaft and serves toconnect a pressure device via which pressurized fluid is introducedthrough channels provided in the fitting so as to expand the balloon atthe distal end of the catheter shaft.

In view of the above, there exists a need for an improved catheter. Thisinvention addresses this need art as well as other needs, which willbecome apparent to those skilled in the art from this disclosure.

SUMMARY OF THE INVENTION

Investigations conducted within the scope of the present invention haveshown that the transition point between hypotube and fitting is verysensitive to kinking. The user may kink the catheter shaft when removingthe shaft from the packaging and the protective cover or when connectingthe pressure device. Investigations conducted within the scope of thepresent invention have shown that at least one of the reasons for saidundesired kinking is the fact that the catheter shaft has a very smalldiameter so that, when removing the catheter shaft from the packaging orwhen connecting the pressure device, the user does not feel the cathetershaft in a sufficiently distinct way and may thus kink it withoutintention Kinking is particularly critical for the reason that it maylead to an occlusion of the inflation lumen, which makes the catheterinoperative.

It is therefore the object of the present invention to provide acatheter which has improved handling characteristics and is particularlynot prone to kinking

This object is achieved through a catheter comprising a catheter shaftincluding a proximal end and a distal end having preferably securedthereto a balloon, and a fitting, preferably a luer fitting, arranged atthe proximal end of the catheter shaft. The proximal end of the cathetershaft can include a bending section.

Although the generic prior art according to U.S. Pat. No. 5,569,200refers to the sensitivity to kinking and to the provision of slits inthe catheter shaft as a possible solution for this problem, slits areprovided at the distal end, at which point no forces are acting in adirection transverse to the longitudinal axis of the catheter, sincethere are only forces applied in the direction of the longitudinal axisof the catheter. In this respect the slits cannot solve theabove-explained problem because in the generic catheter there is stillthe risk of kinking or even breaking upon application of externalforces, as has been described above.

By contrast, the deliberate provision of a bending section at theproximal end of the catheter shaft in accordance with the inventionsolves the technical problem underlying the invention in a surprisinglysimple and unforeseeable way because the deliberate provision of abending section exactly in the critical region of the catheter shaftthat is particularly sensitive to kinking in the generic cathetercreates increased flexibility which, although it permits an intendedbending, reliably prevents undesired kinking or even breaking because aplastic deformation of the catheter shaft is prevented.

U.S. Pat. No. 6,387,075 discloses a further catheter which has a spiralcut into the hypotube distally of the woven catheter shaft. Said spiral,however, is just meant to improve the flexibility of the catheter shaftin the distally situated region of the catheter. Therefore, according tothe above-mentioned U.S. Pat. No. 5,569,200, the spiral cannot preventthe risk of kinking of the catheter behind the fitting.

Furthermore, it is described in U.S. Pat. No. 6,387,075 that forpreventing kinking of the catheter behind the fitting the proximalcatheter shaft is reinforced with a polymer over a length of about 6 to12 inches or stabilized by way of reinforcement. Said reinforcement,however, just shifts the point of kinking in distal direction towardsthe end of the reinforcement. Moreover, the polymer reinforcementreduces the available and usable length of the catheter, thus resultingin an undesired extension of the catheter shaft.

Finally, in a further embodiment for reinforcing the proximal cathetershaft, U.S. Pat. No. 6,387,075 describes a catheter whose proximal shaftconsists, instead of a hypotube, of a woven fabric placed between aninner and an outer polymer tube. This embodiment avoids the problem ofkinking of the catheter by installation of a catheter section that doesnot consist of the hypotube, but is made up of novel additional shaftcomponents. This, however, entails considerable drawbacks due to reducedpushability and a troublesome and expensive production of the catheter.

When the bending section of the present invention is designed as acut-in spiral or as a plurality of offset cuts or incisions withsuitable seals, this will entail the advantage that the bending sectioncan be produced in a very simple manner without the use of additionalmaterials, which reliably prevents damage to the catheter shaft. Thisyields a deliberate weakening of the material that leads to the desiredincrease in flexibility and thus kink protection.

According to another aspect of the present invention, the bendingsection is designed as a soft-annealed material section of the cathetershaft which in a particularly advantageous embodiment can be surroundedby a spiral spring for enhancing the stability thereof.

As a rule, it is also possible to form the bending section as atransitional section of the fitting from a flexible plastic material,which in a particularly preferred embodiment has an undercut which canbe engaged by a complementary holding member of the proximal end of thecatheter shaft for securing the position.

In a further alternative embodiment, the bending section is formed by aplurality of balls which are mounted on the proximal end of the cathetershaft. The balls can be provided on the catheter shaft (hypotube) eithermechanically, or they may be formed thereon by an adhesive, by weldingor as one piece. Furthermore, it is possible to provide a heatshrinkable tube over the balls for fixing the position.

One object according to the invention is achieved in this embodiment bymechanically restricting the maximum bending degree or converting thebending operation into a sufficiently large radius, which also preventsa plastic deformation of the plastic dimension or at least reduces it toa tolerable degree.

The arising forces that are greater than a possible maximum bendingangle can be converted into longitudinal stress on the catheter shaftwhich is able to withstand said stress due to its materialcharacteristics much better than bending forces.

Finally, it is fundamentally possible to form a spring on the proximalend of the catheter shaft, e.g. in the form of a flexible spiral springwhich is connected to the fitting in the kink-prone region, so that theplastic deformation of the catheter shaft itself can also be prevented.

These and other objects, features, aspects and advantages of the presentinvention will become apparent to those skilled in the art from thefollowing detailed description, which, taken in conjunction with theannexed drawings, discloses a preferred embodiment of the presentinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

Referring now to the attached drawings which form a part of thisoriginal disclosure:

FIG. 1 is a schematically strongly simplified illustration of a catheteraccording to the present invention;

FIGS. 2 and 3 are illustrations corresponding to FIG. 1, which showpossible designs of the bending section in the form of offset cuts;

FIG. 4 is an illustration corresponding to FIG. 1, which shows a secondembodiment of the catheter according to the present invention;

FIG. 5 is an enlarged illustration of detail A in FIG. 4;

FIG. 6 is an illustration corresponding to FIG. 1, which shows a third,fundamentally possible embodiment of the catheter according to theinvention; and

FIGS. 7-9 are illustrations showing parts of the catheter illustrated inFIG. 6, for explaining the function of the embodiment.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Selected embodiments of the present invention will now be explained withreference to the drawings. It will be apparent to those skilled in theart from this disclosure that the following description of theembodiments of the present invention is provided for illustration only,and not for the purpose of limiting the invention as defined by theappended claims and their equivalents.

Referring initially to FIG. 1, a catheter 1 is illustrated in accordancewith a first embodiment of the present invention. The catheter 1 of thepresent invention basically comprises a catheter shaft 2 provided with aproximal end 3 and a distal end 4, which are shown in FIG. 1 in astrongly shortened condition. A balloon 24, which is only illustratedschematically, is secured to the distal end 4. Furthermore, the catheter1 comprises a fitting 5 which is normally designed as a luer fitting.The fitting 5 is secured to the proximal end 3 of the catheter shaft 2and may comprise a housing 25 of a standard construction with apassageway 26 in flow communication with the catheter shaft 2. Thefitting 5 is connected to a pressure device (inflation device) forexpanding the balloon 24.

The proximal end 3 of the catheter shaft 2 of the catheter 1 accordingto the invention is provided with a bending section 6 having aflexibility greater than that of the section 3′ of the catheter shaft 2joining the proximal end 3. Said bending section 6 prevents unintendedkinking in the way explained at the outset.

In the embodiment which is shown in FIG. 1 and particularly preferred,the bending section 6 is designed as a spiral 7 that is cut into thecatheter shaft 2 and formed with a selectable number of spiral sections.

For preventing liquid from exiting, the spiral 7 is provided with a seal8 which may be designed as a sleeve or tube that is secured, preferablyby an adhesive, to the proximal section 3.

As illustrated in FIG. 1, the proximal end 3 is connected with itsbending section 6 and the seal 8 arranged thereabove to a transitionmember 16 of the fitting 5, so that the region of the catheter shaft 2that is prone to kinking is protected from unintended kinking

FIGS. 2 and 3 show alternative embodiments of the bending section 6. Inthe embodiment shown in FIG. 2, the bending section 6 is formed at theproximal end 3 by a plurality of offset slits, which in the exemplarycase are represented by two slits 9 and 11. The slits 9 and 11 extend upto webs 10 and 12, respectively, the arrangement of which yields theoffset. The slits can be adapted in their dimensions (length, width,angular position) to different conditions of use.

In FIG. 3, the bending section 6 is also formed at the proximal end 3 bya plurality of offset slits 13, 14 and 15, which in this embodiment donot extend in circumferential direction as in FIG. 2, but extendessentially in the longitudinal direction of the proximal end 3. Theslits 13 and 15 have two slit sections, of which one extends into theedge portion of the proximal end 3 while the slit 14 comprises threeslit sections arranged at an angle relative to one another between slits13 and 15.

Second Embodiment

Referring now to FIGS. 4 and 5, a catheter 1 in accordance with a secondembodiment will now be explained. hi view of the similarity between thefirst and second embodiments, the parts of the second embodiment thatare identical to the parts of the first embodiment will be given thesame reference numerals as the parts of the first embodiment. Moreover,the descriptions of the parts of the second embodiment that areidentical to the parts of the first embodiment may be omitted for thesake of brevity. Reference can here be made to the above explanations.

In the embodiment according to FIG. 4, the transition member 16 isformed as a flexible plastic section of the fitting 5 that is connectedto the proximal end 3 of the catheter shaft 2. The detail according toFIG. 5 shows an undercut 17 which can be engaged by a holding member 18of the proximal end 3 of the catheter shaft 2 for fixing the cathetershaft 2.

Third Embodiment

Referring now to FIG. 6, a catheter 1 in accordance with a thirdembodiment will now be explained. In view of the similarity between thethird and prior embodiments, the parts of the third embodiment that areidentical to the parts of the prior embodiments will be given the samereference numerals as the parts of the prior embodiments. Moreover, thedescriptions of the parts of the second embodiment that are identical tothe parts of the first embodiment may be omitted for the sake ofbrevity. Reference can here be made to the above explanations.

In this embodiment, the bending section 6 comprises a plurality of balls19 to 23 mounted on the proximal end 3. Said balls can be fixed to thecatheter shaft 2 by way of different fastening possibilities as havebeen explained at the outset. In the embodiment shown in FIG. 6, a heatshrinkable tube 27 is provided for this purpose, said tube beingconnected at one end to the catheter shaft 2 and fixed at the other endto the fitting 5.

FIGS. 7 and 8 illustrate the function of the embodiment with referenceto two balls 19 and 20. It becomes apparent that the balls can bedimensioned in their distance d and in their radius r (see FIG. 9) insuch a way that a maximally acceptable bending angle a (see FIG. 9) ismade possible. This angle a does not entail any plastic deformation andthus kinking or even breaking of the catheter shaft.

Catheters without a balloon shall also be regarded as cathetersaccording to the invention.

The terms of degree such as “substantially”, “about” and “approximately”as used herein mean a reasonable amount of deviation of the modifiedterm such that the end result is not significantly changed. These termsshould be construed as including a deviation of at least −±5% of themodified term if this deviation would not negate the meaning of the wordit modifies.

This application claims priority to European Patent Application No.02027767.9: The entire disclosure of European Patent Application No.02027767.9 is hereby incorporated herein by reference.

While only selected embodiments have been chosen to illustrate thepresent invention, it will be apparent to those skilled in the art fromthis disclosure that various changes and modifications can be madeherein without departing from the scope of the invention as defined inthe appended claims. Furthermore, the foregoing descriptions of theembodiments according to the present invention are provided forillustration only, and not for the purpose of limiting the invention asdefined by the appended claims and their equivalents.

What is claimed is:
 1. A medical device comprising: a catheter shafthaving a proximal-most end, a distal end, and a section of the cathetershaft located distal to the proximal-most end of the catheter shaft; aballoon secured to the distal end; a luer fitting capable of beingconnected to a pressure device and arranged at the proximal-most end ofthe catheter shaft; the proximal-most end of the catheter shaftincluding a plurality of balls spaced to provide kink-free bending ofthe proximal-most end so as to avoid kinking the proximal-most end ofthe catheter shaft when removing the catheter shaft from packaging orwhen connecting the pressure device; the section of the catheter shaftlocated distal to the proximal-most end of the catheter shaft is lessflexible than the proximal-most end of the catheter shaft; and a heatshrinkable tube disposed over the plurality of balls; wherein the heatshrinkable tube is connected at a first end to the catheter shaft and ata second end to the luer fitting.
 2. The medical device of claim 1,wherein the plurality of balls are affixed to the catheter shaft bywelding.
 3. The medical device of claim 1, wherein the catheter shaftand the plurality of balls are one piece.
 4. The medical device of claim1, wherein a spacing of the plurality of balls is selected to define amaximum bending angle above which bending forces applied to the cathetershaft are converted to longitudinal stresses along the catheter shaft.5. A medical device comprising: a hypotube having a proximal end and adistal end; a balloon secured to the distal end of the hypotube; and afitting arranged at the proximal-most end of the hypotube, theproximal-most end of the hypotube including a bending section to providekink-free bending of the proximal-most end, the bending sectionincluding a plurality of balls, wherein the plurality of balls areaffixed to the hypotube using a heat shrinkable tube disposed over theplurality of balls and the heat shrinkable tube is connected at a firstend to the hypotube and at a second end to the fitting.
 6. The medicaldevice of claim 5, wherein the plurality of balls are affixed to thehypotube by an adhesive bond.
 7. The medical device of claim 5, whereinthe plurality of balls are mechanically coupled to the hypotube.
 8. Themedical device of claim 5, wherein the plurality of balls are separatedby a distance d and have a radius r to define a maximum acceptablebending angle α.
 9. The medical device of claim 8, wherein the angle αis selected to prevent kinking of the hypotube.
 10. A medical devicecomprising: a catheter shaft having a proximal end and a distal end; anda luer fitting arranged at the proximal-most end of the catheter shaft,the proximal-most end of the catheter shaft including a plurality ofballs spaced apart a distance d to provide kink-free bending of theproximal-most end of the catheter shaft; wherein a heat shrinkable tubeis disposed over the plurality of balls, and the heat shrinkable tube isconnected at a first end to the catheter shaft and at a second end tothe luer fitting.
 11. The medical device of claim 10, wherein a balloonis secured to the distal end of the catheter shaft.
 12. The medicaldevice of claim 10, wherein the catheter shaft includes a lumen and theluer fitting includes a passageway in fluid communication with thelumen.
 13. The medical device of claim 10, wherein the plurality ofballs are affixed to the catheter shaft by an adhesive bond or welding.14. The medical device of claim 10, wherein the catheter shaft and theplurality of balls are one piece.
 15. The medical device of claim 10,wherein the plurality of balls have a radius r, and the combination ofthe distance d and the radius r defines a maximum acceptable bendingangle α.
 16. The medical device of claim 15, wherein the angle α isselected to prevent kinking of the catheter shaft.